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Optimer Pharmaceuticals and Cubist Pharmaceuticals Announce Collaboration to Co-Promote DIFICID™ (Fidaxomicin) for Clostridium difficile Infection in the United States
Date:4/6/2011

I, DIFICID was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI.  DIFICID also demonstrated statistically significant reduction in recurrences and an increase in global cure rate, defined as cure without recurrence. Importantly, DIFICID reduced the risk of recurrence by 47% compared to vancomycin. The New England Journal of Medicine has published results from the first Phase 3 trial in an article titled, "Fidaxomicin versus Vancomycin for Clostridium difficile Infection," which appeared in the February 3, 2011 issue.  Optimer filed a marketing application in the EU for DIFICID for the treatment of CDI and reducing risk of recurrence when used for treatment of initial CDI.  

About Clostridium difficile Infection (CDI)

Clostridium difficile infection (CDI), commonly referred to as "C. difficile" or "c-diff", has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the U.S.  It is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death.  Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, thus allowing C. difficile bacteria to flourish and produce toxins.

Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the latter being the only FDA-approved treatment.  However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of the CDI treatment.

Primary risk factors for CDI include broad-spectrum antibiotic use
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SOURCE Optimer Pharmaceuticals, Inc.
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1. Optimer Announces that the U.S. Food and Drug Administrations Anti-Infective Drugs Advisory Committee Voted Unanimously to Recommend Approval of Novel Antibiotic Dificid™ for Treatment of Patients with Clostridium difficile infection (CDI)
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3. Optimer Pharmaceuticals Announces Presentation at SHEA of Data Highlighting the Burden of Clostridium difficile Infection (CDI) in Hospital Patients
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